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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01106651




Registration number
NCT01106651
Ethics application status
Date submitted
1/04/2010
Date registered
20/04/2010
Date last updated
4/11/2014

Titles & IDs
Public title
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy
Secondary ID [1] 0 0
28431754DIA3010
Secondary ID [2] 0 0
CR017014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Canagliflozin 100 mg
Treatment: Drugs - Canagliflozin 300 mg
Treatment: Drugs - Antihyperglycemic agent(s)
Treatment: Drugs - Placebo

Experimental: Canagliflozin 100 mg - Each patient will receive 100 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Experimental: Canagliflozin 300 mg - Each patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Placebo comparator: Placebo - Each patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.


Treatment: Drugs: Canagliflozin 100 mg
One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Treatment: Drugs: Canagliflozin 300 mg
One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Treatment: Drugs: Antihyperglycemic agent(s)
Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\] inhibitors, metformin, insulin \[all types\]) and their combinations (sulfonylurea agent and insulin \[all types\], metformin and insulin \[all types\], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\]) are used as per protocol specifications.

Treatment: Drugs: Placebo
One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 26
Timepoint [1] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [1] 0 0
Percentage of Patients With HbA1c <7% at Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Timepoint [2] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [3] 0 0
Percent Change in Body Weight From Baseline to Week 26
Timepoint [3] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [4] 0 0
Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Timepoint [4] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [5] 0 0
Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Timepoint [5] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [6] 0 0
Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Timepoint [6] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [7] 0 0
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Timepoint [7] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [8] 0 0
Percent Change in Triglycerides From Baseline to Week 26
Timepoint [8] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [9] 0 0
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Timepoint [9] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [10] 0 0
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [10] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [11] 0 0
Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [11] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [12] 0 0
Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [12] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [13] 0 0
Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
Timepoint [13] 0 0
Day 1 (Baseline) and Week 26

Eligibility
Key inclusion criteria
* All patients must have a diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)
* Patients in the study must have a HbA1c between >=7 and <=10.0%
* Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
716
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fremantle
Recruitment hospital [2] 0 0
- Heidelberg Heights
Recruitment hospital [3] 0 0
- Meadowbrook
Recruitment hospital [4] 0 0
- Richmond
Recruitment postcode(s) [1] 0 0
- Fremantle
Recruitment postcode(s) [2] 0 0
- Heidelberg Heights
Recruitment postcode(s) [3] 0 0
- Meadowbrook
Recruitment postcode(s) [4] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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Arkansas
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California
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Florida
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Georgia
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Kansas
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Massachusetts
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Nevada
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New Mexico
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North Carolina
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North Dakota
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Ohio
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South Carolina
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Tennessee
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Texas
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Washington
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Canada
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British Columbia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Colombia
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Barranquilla
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Colombia
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Bogota
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France
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Corbeil Essonnes
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France
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Paris
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France
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Venissieux
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Greece
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Thessalonikis
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Greece
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Thessaloniki
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Hong Kong
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Sha Tin
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India
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Bangalore
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India
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Nagpur
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India
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Pune
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Auckland
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New Zealand
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Christchurch
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Tauranga
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Wellington
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Krakow
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Torun
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Warszawa
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Wroclaw
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Romania
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Bucharest
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Romania
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Sibiu
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South Africa
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Pretoria
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Spain
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Granada
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Spain
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Madrid
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Spain
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Pozuelo De Alarcon
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Spain
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Sevilla
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Sweden
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Göteborg
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Sweden
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Uppsala
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Switzerland
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Bruderholz
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Switzerland
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St Gallen
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Ukraine
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Kharkov
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Ukraine
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Kiev
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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Glasgow
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Liverpool
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Manchester
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Reading
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United Kingdom
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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01106651